10-15 years in a regulated life science environment
Proficient in project management principles
Strong interpersonal and communication skills
Background in business development
Expertise in organizational strategy and change management
Extensive knowledge of global submission standards (FDA, HC, EMA, ICH)
Familiarity with eCTD systems and regulatory information management
Responsibilities
Develop and execute innovative regulatory strategies for drug development
Manage daily operations using project management tools and timelines
Establish and communicate regulatory positions on development issues
Review client programs and create strategic plans for development
Ensure compliance with ICH and local regulatory requirements
Initiate and author SOPs and work instructions for regulatory operations
Serve as the primary regulatory liaison with agencies
Benefits
Opportunity to lead significant regulatory initiatives
Engagement in strategic planning for global expansion
Involvement with innovative drug development projects
Collaboration with cross-functional development teams
Supportive environment for professional growth and learning
Full Job Description
Job Description
We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will:
Develop and execute novel drug regulatory strategy
Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines
Establish sound regulatory advice/position on key development issues, and communicate same to the respective stakeholders
Provide a high-level review of client programs and develop strategic plans for clinical, analytical, and process development
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
Initiate, author, and/or collaborate on SOP's, work instructions and Work Flows for the regulatory operations function. e.g. electronic Common Technical Document (eCTD) Investigational and Marketing Applications, and post-marketing compliance maintenance submissions in the United States, Europe, and RoW
Author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging
Work closely with the development team to ensure overall regulatory strategy, regulatory CMC strategy, and labeling strategy for Pharmaceutical/Biological products are aligned
Be the point of contact between the company and the regulatory agency - serve as the regulatory liaison
Help strategize a road map for EU expansion: MAA planning (Type of submissions - DCP, CP, NP, MRP, Country(ies) selection for MAA and for being CMS vs. RMS and Inputs to set up EU QPPV Office
Desirable Skills and Experience
10 - 15 years' experience working in a regulated, life science environment
Strong project management skills
Good interpersonal skills
Business development skills
Experience in defining organizational strategy, process and change management, KPIs and metrics, resource forecasting
Extensive knowledge of global submission standards, including but not limited to FDA, HC, EMA, ICH, eCTD and industry trends for dossier preparation (IND/CTA/NDA/MAA/NDA) and regulatory change management and operations.
Knowledge on RoW markets is a plus
Experience in medical device regulations is a plus
Knowledge of eCTD publishing systems, TRS toolbox, and related tools
Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
